FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134665–134688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1988
AERO-MIST NEBULIZER
K881812 · IYT
Cadema Medical Products, Inc.
Radiology · 81d
Cleared Jul 18, 1988
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
K881820 · DQA
Edentec Corp.
Anesthesiology · 80d
Cleared Jul 18, 1988
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · DXY
Telectronics, Inc.
Cardiovascular · 77d
Cleared Jul 18, 1988
FRANZ CATHETER
K881853 · DRF
Ep Technologies, Inc.
Cardiovascular · 76d
Cleared Jul 18, 1988
SATLITE+/PB251+ PULSE OXIMETER
K881883 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 75d
Cleared Jul 18, 1988
SIRECUST 1280/1281 & 960/961 PATIENT MONITORS
K881939 · DPS
Siemens Medical Electronics
Cardiovascular · 70d
Cleared Jul 18, 1988
SPINAL NEEDLE
K882073 · GDM
Karlin Technology, Inc.
General & Plastic Surgery · 62d
Cleared Jul 18, 1988
STERILE PACK (PROCEDURAL TRAY/KITS)
K882275 · LRP
East Texas Lighthouse For the Blind
General & Plastic Surgery · 48d
Cleared Jul 18, 1988
EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
K882286 · GWM
Metatech Corp.
Neurology · 47d
Cleared Jul 18, 1988
SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL
K882299 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 46d
Cleared Jul 18, 1988
STETH-SHIELD ACCESSORY TO A STETHOSCOPE
K882324 · LDE
Steth-Shield, Inc.
Cardiovascular · 42d
Cleared Jul 18, 1988
QUICK CONNECT T ADAPTOR
K882341 · BZO
Thayer Medical Corp.
Anesthesiology · 41d
Cleared Jul 18, 1988
SOC SLIDE CULTURE SYSTEM
K882371 · JXC
The Cancer Center AT Wadley Institutes
Microbiology · 40d
Cleared Jul 18, 1988
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · BXN
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 34d
Cleared Jul 18, 1988
26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP
K882479 · DWS
Medtronic Blood Systems, Inc.
Cardiovascular · 32d
Cleared Jul 18, 1988
DIVERSI-KIT
K882485 · LIO
Intl. Cancer Screening Laboratories,...
Microbiology · 32d
Cleared Jul 18, 1988
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · GIM
Terumo Medical Corp.
Hematology · 31d
Cleared Jul 18, 1988
SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS
K882520 · LWG
Karlin Technology, Inc.
General & Plastic Surgery · 31d
Cleared Jul 18, 1988
GAUZE SPONGE
K882527 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 27d
Cleared Jul 18, 1988
CYLINDRICAL SPONGE
K882528 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 27d
Cleared Jul 18, 1988
BUTCHER STRUNG TONSIL SPONGE
K882529 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 27d
Cleared Jul 18, 1988
TAPE STRUNG TONSIL SPONGE
K882530 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 27d
Cleared Jul 18, 1988
HEMOCUE HEMOGLOBIN CALIBRATOR
K882600 · KRZ
React and Co.
Hematology · 24d
Cleared Jul 18, 1988
ALM SURGICAL LAMPS
K882613 · FTD
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 24d